Teva Pharmaceuticals USA, Inc recalls Carton label: Testosterone Gel 1%
- Recalling company
- Teva Pharmaceuticals USA, Inc
- Product
- Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavis Laboratories, Inc, Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-3216-30. Packet label: Testosterone Gel 1%, contains 2.5 grams, For topical use only, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054,NDC: 0591-3216-17.
- Reason
- Defective Container - A defect in the side-seal which allows leakage of product.
- Classification
- Class III – not likely to cause adverse health consequences
- Recall date
- Nov 7, 2025
- Reported
- Dec 10, 2025
- Distribution
- U.S. Nationwide
- Status
- Ongoing
- Quantity
- 15,944 cartons
- Lot / codes
- Lot #100068692, Exp.: 04/30/2027
- Company location
- Parsippany, NJ
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0198-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0198-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.